Status:
RECRUITING
Esketamine Combined Pulsed Radiofrequency for Acute/Subacute Zoster-associated Trigeminal Neuralgia
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Beijing Xiaotangshan Hospital
The First Hospital of Fangshan District,Beijing
Conditions:
Zoster; Herpes, Trigeminal Neuralgia (Etiology)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To assess the 1-month effects and safety of esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute zoster-related trigeminal neuralgia(ZRTN).
Detailed Description
The investigators aim to investigate whether or not esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute ZRTN , and seek a safe, and effective treatment f...
Eligibility Criteria
Inclusion
- Age \>18 years;
- History of HZ within the last three months;
- Lesions located in the trigeminal nerve or its branches innervated regions；
- Numeric Rating Scale (NRS) pain score≥4 (NRS, 0 = no pain, 10= worst possible pain) with pharmacotherapy;
- Planned to perform CT-guided PRF treatment of the Gasserian ganglion .
Exclusion
- Obstructive sleep apnoea syndrome;
- Those who receive other invasive treatments, such as spinal cord stimulation;
- A history of systemic immune diseases, organ transplantation, or cancers;
- A history of severe cardiopulmonary, hepatic or renal dysfunction;
- A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
- Comorbid hyperthyroidism or phaeochromocytoma;
- Recent history of drug abuse;
- Having contraindications to esketamine;
- Communication difficulties.
- Withdrawal criteria
- Lost to follow-up during the study;
- Not perform the planned operation;
- Receiving other treatment regimes during the study period;
- Not suitable for continuing the study for emerging severe comorbidities or special physiological changes during the study;
- Voluntary withdrawal from the study.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT06890897
Start Date
April 1 2025
End Date
September 30 2026
Last Update
April 27 2025
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, China, 100050